LoCoMo: Long COVID in Military Organisations

Sponsor
University of Zurich (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04942249
Collaborator
Labor Speiz (Other), Swiss Armed Forces (Other), Universitatsspital Zurich (Other)
500
1
7.4
67.6

Study Details

Study Description

Brief Summary

A prospective, longitudinal cohort study designed to follow-up on 500 Swiss military personnel who tested in 2020 for SARS-CoV-2 (regardless of whether positive or negative, but with a known test result). Participants are invited to undergo an intensive test battery to evaluate if they suffer COVID-19 sequelae. The testing will include evaluation of several body systems (cardio-vascular, pulmonary, neurological, ophthalmological, psychological and general) and male fertility in a voluntary subgroup. Immune markers and SARS-CoV-2 reinfection rates will also be evaluated. The study hypothesis is that SARS-CoV-2 infection causes a multi-system disease with sequelae detectable in a significant proportion of army recruits after infection with SARS-CoV-2.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

During the COVID-19 pandemic, many members of the Swiss armed forces (SAF) contracted SARS-CoV-2. Up to one fifth may suffer from long-term sequelae, or so-called "Long COVID". The "LoCoMo" study is a prospective, longitudinal cohort study designed to follow-up on 500 tested recruits who tested either positive or negative while serving in the SAF in early 2020.

The aim of this research project is to evaluate long-term sequelae that may have occurred in members of the armed forces. By following up on those army recruits who tested positive and who were either symptomatic or asymptomatic and comparing them with those who test negative; symptoms and sequelae of the infection and impact on life quality can be tracked. The acquired data will also provide insights into the duration of immunity (or lack thereof) after symptomatic and asymptomatic infection and the kinetics of antibody decline in those who test positive. Furthermore, the study allows to follow-up on those army recruits who have confirmed positive tests for SARS-CoV-2 and to compare them to those who were negative. The data collected with this extensive test battery allows for a follow-up on a wide range of symptoms, estimated rates of re-infection as well as long- term sequelae after infection, including impact on ophthalmological function, on life quality and activities and impact on male fertility.

The results of the study can also be extrapolated to health-care workers and other young adults who constitute the backbone of the workforce. Because the proposed test battery is very broad and comprehensive it may also detect hitherto unknown, long-term sequelae, which might provide insight in the pathophysiology and general understanding of consequences of SARS-CoV-2 infection which is the basis to develop strategies to mitigate the sequelae. This study will provide essential knowledge on the multi-organ impact of COVID-19 in young persons in Switzerland.

Study Design

Study Type:
Observational
Actual Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long COVID in Military Organisations
Actual Study Start Date :
May 20, 2021
Anticipated Primary Completion Date :
Oct 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Symptomatic

167 symptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020

Other: No intervention
No intervention

Asymptomatic

167 asymptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020

Other: No intervention
No intervention

No evidence of infection

167 Swiss army recruits with no evidence of infection (who also were tested for SARS-CoV-2 in 2020)

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. to longitudinally follow-up on a cohort of 500 military who tested either positive or negative for SARS-CoV-2 in early 2020 for possible sequelae, one year post infection [One year]

    The primary endpoint is the occurrence of SARS-CoV-2 infection sequelae in a longitudinally follow-up cohort of a total of 500 military who tested either positive or negative for SARS-CoV-2 in early 2020.

Secondary Outcome Measures

  1. Outcomes from components of the test battery [One year]

    The test battery will detect anticipated sequelae in the following categories: general systemic, pulmonary, cardiac, male fertility, psychological, ophthalmological.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Army recruits and personnel who tested for SARS-CoV-2.

  • Completion of a consent form.

  • Willing to participate and to complete the testing day in Zürich.

Additional inclusion criteria solely for the voluntary spermiogram test:
  • Male

  • No known abnormality of the reproductive system (e.g. Klinefelter-Syndrome)

Exclusion Criteria:
  • Unwilling to provide consent. Unable to attend the testing day in Zurich.

  • A narrow-angle glaucoma or sensitivity to a component of the Tropicamide eye drops is not an exclusion criterion, but the eye examination will be performed without pharmacological mydriasis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Epidemiology, Biostatistics and Prevention Institute at the University of Zurich Zürich Switzerland 8001

Sponsors and Collaborators

  • University of Zurich
  • Labor Speiz
  • Swiss Armed Forces
  • Universitatsspital Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Patricia Schlagenhauf, Prof. Dr., University of Zurich
ClinicalTrials.gov Identifier:
NCT04942249
Other Study ID Numbers:
  • 2021-00256
First Posted:
Jun 28, 2021
Last Update Posted:
Jun 28, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 28, 2021